Job Summary

A clinical and scientific staffing company needs applicants for an opening for a Remote Principal Medical Writer Consultant.

Must be able to:

• Draft, edit, format, and finalize clinical regulatory documents
• Provide quality control (QC) review of clinical regulatory documents, as appropriate
• Produce high quality and on-time writing deliverables to support the activities and goals of the clinical study team(s)

Required Skills:

• A minimum of 5 years medical writing experience in the biopharmaceutical industry
• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process
• Strong written and verbal communication skills, including fluency in oral and written English
• Regulatory submissions and knowledge of eCTD formatting preferred
• Bachelors degree in a relevant scientific field is required; advanced degree preferred